There have been some issues involving informed consents documents for participants on the IDEAS study. Please see reminders below and let us know if you have any questions. The Code of Federal Regulations (CFR) mandates certain requirements for the informed consent process.*
- The Consent Process involves BOTH written and verbal consent.
- All Participants MUST be consented prior to taking part in any research related activities.
- The final step in the consent process MUST include written consent whereby a participant agrees to be involved in research and is “fully informed” about the study.
- All participants MUST sign the correct current IRB approved consent document.
- Schulman IRB provides the referring physician practice a unique, STAMPED consent document that MUST be used with the potential participant. Sites may obtain the STAMPED and dated version of both the participant (patient) informed consent document as well as the one for the referring physicians (dementia specialist) at the Schulman portal.
- As of early January, a revised participant informed consent document was provided to Schulman-approved sites as part of the approval of Amendment 1. Please make sure that you have downloaded the recent informed consent document for your site and are using the correct one with potential participants. Please be sure to access the amended protocol at http://www.ideas-study.org/referring-physicians/protocol/.
- NOTE: The appendices at the back of the protocol document are NOT approved informed consent documents.
Below is a screenshot of the IRB page on the IDEAS Study website at: http://www.ideas-study.org/referring-physicians/institutional-review-board/. The highlighted item is a set of screenshots for accessing approval documents provided by Schulman IRB.
How to access the Schulman portal to obtain your approval documents
Example of IRB approved consent document below
All sites submitting study documents to Schulman do so via a secure portal, by accessing www.sairb.com and choosing login to Schulman eTools. Access to all approved site study documents is available through login to the Schulman Webportal 3D from www.sairb.com and choosing the Study Documents feature and clicking the envelope associated with the document type Amended Approval Letter with Revised ICD. Please ensure you are using the correct version to consent potential participants.
Please see STAMP sample below. The stamp date is your site’s approval date. The VERSION date will be at the bottom of the page.
Should you have questions, please contact IDEAS-Regulatory@acr.org or Maria Stivers (Schulman IRB) at firstname.lastname@example.org.
* Always remember that Informed consent is a continuous process that is must comply with 45 Code of Federal Regulations (CFR) 46.116. General requirements for informed consents and 45 CRF 46.117 Documentation of informed consents.